Drugmaker Zydus Lifesciences has received the United States Food and Drug Administration (USFDA) approval to market Brivaracetam tablets.
An antiepileptic drug, the approved product is a generic of multinational pharma firm UCB’s Briviact. “U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received the final approval from the USFDA to market Brivaracetam Tablets USP 10mg, 25mg, 50mg 75mg and 100mg,“ Zydus said in a statement on October 6.
Since it was “one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Brivaracetam Tablets USP 10mg, 25mg, 50mg, 75mg and 100mg, it is eligible for 180 days of shared generic drug exclusivity,” it said.
Zydus gets USFDA approval for generic drug
The approved drug had annual sales of $412 million in the U.S., the company said citing IQVIA numbers. Brivaracetam is indicated for the treatment of partial-onset seizures in patients four years of age and older.
“The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad,” Zydus said.
